METHODOLOGY
Figure 1: Schematic workflow diagram of an effective technology transfer practice. (ALL FIGURES COURTESY OF THE AUTHORS)
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Figure 1 demonstrates an example of effective technology transfer practice used when a fully developed production process
is transferred from a sending company to a receiving company for GMP manufacturing of a biopharmaceutical product. The technology
transfer activities often start with the transfer of documents from the technology sending site to the receiving site. The
technology transfer document package and technical communications between both sites should provide sufficient process understanding
at the receiving site. With understanding of the process and the product requirement, the GMP manufacturing process can be
designed on paper.
If GMP manufacturing is attempted at this stage based on the design on paper, the chance of success would be slim. Confirming
technical feasibility and performance of the designed GMP-scale process by a small-scale prototype process would minimize
the risk at lower cost. Therefore, a small-scale prototype process is designed and executed by directly scaling-down the designed
GMP process. The designed GMP process may undergo redesign or changes based on any technical unsuitability experienced during
the execution of small-scale runs and after evaluating the performance of small-scale prototype process runs.
Not all parameters and conditions applicable in a large-scale process can be mimicked exactly in a small-scale prototype run.
Therefore, a full GMP scale process run, often called an engineering or technical run, using the GMP batch production protocols
and equipment prior to the actual GMP runs, justifies the success of the GMP batch at first attempt. The product produced
from such a successful engineering run can also be used for preclinical studies, a stability study, or assay qualification
or validation. The design of the GMP process may again undergo redesign or changes based on the technical feasibility and
performance of the engineering run.
THE DOCUMENT PACKAGE
Transferring documents containing the process description is usually the first activity to take place during a technology
transfer program after the business agreement is signed. A typical technology transfer package includes the following documents:
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Process description: It is the responsibility of the sending site to provide a detailed description of the final process they would like to transfer.
The process description should contain all process parameters and conditions, and be as detailed as possible. Some important
parameters that a process description must contain can be found in the next section of this article.
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Production protocols: Prior to, or at the early stage of technology transfer, the developed final process is run a few times at the site where
it was developed. The availability of production protocols should provide the details of how each process step was originally
performed, which are typically not covered in a process description document.
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Process development report: The process development site must document why certain decisions were taken and why certain parameters or conditions were
selected while others are not during process development. Availability of this document to the technology receiving site allows
understanding of critical process parameters and enables decisions about how to execute each process step with acceptable
margin of all parameters and conditions.
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